The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01423734
First received: August 24, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

Imaging with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) is normally used to see how tumors respond to treatment. If tumors shrink after therapy, doctors continue with the same treatment. On the other hand, growing tumors in a patient can bring about a change in therapy. Unfortunately, it often takes three to six months, or even longer before the investigators see tumors shrink or grow on scans. Doctors are looking for new imaging tools that can look at how tumors respond early on during treatment. This study will help us decide if such an MRI technology called DWI (Diffusion Weighted Imaging) can be used as a helpful imaging tool.


Condition Intervention
Gastro-enteropancreatic Neuroendocrine Tumor
Secondary Malignant Neoplasm of Liver
Other: magnetic resonance imaging (MRI)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study To Assess The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • reproducibility of diffusion weighted imaging for neuroendocrine liver metastases. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The investigators will calculate an ADC value for each metastasis that was chosen through consensus by the two participating radiologists. ADC is a voxel-level measurement so summary measures will be employed in order to get a single measurement for the ROI of each metastasis under study. For both the clinical and research MRI, the investigators will take the voxel-level data and calculate the mean, median, and minimum ADC within each ROI.


Secondary Outcome Measures:
  • evaluate the repeatability of perfusion insensitive diffusion coefficients ADC high of liver metastases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A similar application of the CCC will be employed to assess both intra-observer and interobserver variability separately for ADC high as in the primary aim. The repeatability and reproducibility of the ADC high will then be compared to the most repeatable and reproducible ADC measures identified in Aim 1 by ranking the CCC values and selecting the measure with the highest value.

  • evaluate the reproducibility perfusion insensitive diffusion coefficients (ADC high) of liver metastases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A similar application of the CCC will be employed to assess both intra-observer and interobserver variability separately for ADC high as in the primary aim. The repeatability and reproducibility of the ADC high will then be compared to the most repeatable and reproducible ADC measures identified in Aim 1 by ranking the CCC values and selecting the measure with the highest value.


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI
Patients will be consented for a second MRI without additional intravenous contrast, referred to from now on as 'research MRI', to be performed later on the same day as their clinical liver MR examination, on one of two 3.0 Tesla MR 750 GE scanners at the Breast and Imaging Center. The research MRI will consist only of the localizer and diffusion weighted imaging (DWI) sequences, with acquisition parameters identical to our clinical MRI. The reproducibility of DWI is best assessed in separate MR imaging sessions, although the examinations can be performed the same day.
Other: magnetic resonance imaging (MRI)

Each patient will undergo clinical and research MRI examinations. Before any MRI examination, the patient will answer a standard radiology MR department questionnaire form, with specific questions addressing contra-indications to MRI. The questionnaire form will be reviewed by radiology personnel as per standard practice.

During the research MRI, the patient will be monitored visually and communication will be maintained between the patient and the MR technologists via a speaker system. At the termination of the study, the patient will be evaluated by the MR department radiology personnel as done routinely. Two breath hold DWI sequences will be performed for each patient. Since this is a reproducibility study, identical scan parameters will be used for the clinical and research MRI. The multiple b value DWI will be performed using the enhanced DW sequence that have been recently made available on our 3.0 Tesla MR 750 scanners at the Breast and Imaging Center.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologic evidence of well differentiated neuroendocrine tumor of gastroenteropancreatic origin
  • Evidence of metastatic disease of at least 2.0 cm in the liver by MRI or CT imaging.
  • Patient ≥18 years of age on the day of signing informed consent.

Exclusion Criteria:

  • Any contraindication to MRI based on departmental MR questionnaire
  • Inability to cooperate for an MR exam
  • Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy or one that would not interfere with the MRI results is allowed.
  • Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423734

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Richard Kinh Gian Do, MD,PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01423734     History of Changes
Other Study ID Numbers: 11-122
Study First Received: August 24, 2011
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
ADRENAL GLAND
MRI
11-122

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Neuroendocrine Tumors
Neoplasms, Second Primary
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 28, 2014